RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Please see our Privacy Policy for more information.

The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move
across top level links and expand / close menus in sub levels. Up and Down arrows will open main level
menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab
will move on to the next part of the site rather than go through menu items.

About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

European Marketing Application Rates Set to Increase in 2013

The European Medicines Agency (EMA) has announced that application fees will go up approximately 2.6% in the coming fiscal year, roughly on par with the EU rate of inflation for the previous year.

The exact fee, set to go into effect on 1 April 2013, is not known, EMA noted. That's because the final fee adjustment must be approved by both EMA's Management Board and the European Commission (EC), a process set to conclude in March 2013.

"The European Commission is currently in the process of adopting a regulation adjusting the fees payable to the Agency in line with the 2012 inflation rate," EMA wrote in a statement on its website. "Although the final adjustment is not yet known, the Agency expects its fees to increase by around 2.6%."

"All applications received by 31 March will be charged at the current fee and reduction rates. Applications received after that date will be charged the adjusted fees and be subject to the revised reduction rates, where applicable. For scientific advice and protocol assistance, the cut-off date will be the date of validation of the request for advice."

As of 1 January 2013, fees payable for a basic marketing application were &euro;267,400, with an additional &euro;26,800 for each additional strength or form submitted. Non-dossier applications are charged &euro;172,800, with an additional &euro;10,300 for each additional strength or form.

Based on a 2.6% increase, those fees would be &euro;274,352/&euro;27,497 and &euro;177,272/&euro;10567, respectively. Additional fees, including reduced fees for small- and medium-sized business entities (SMEs), may be found here.

The fees are meant to allow EMA's resources to keep pace with the rate of inflation. Across the EU in 2013, inflation ranged from a low of 2.2% to a high of 3.0%. Early indications for the first half of January 2013 show inflation at just 2.0%, potentially giving EMA a much-needed boost to its purchasing power.